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Technical Documentation Specialist (Medical Devices & ISO 13485) - job post

SDI
3.0 out of 5 stars
Australia
$80,000 - $120,000 a year - Full-time
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Job details

Pay

  • $80,000 - $120,000 a year

Job type

  • Full-time

Location

Australia

Full job description

Location Country
Australia

Vacancy Name
Technical Documentation Specialist (Medical Devices & ISO 13485)

Vacancy No
VN420

Employment Type
Full-Time

Duration

Division
Production Quality

Summary of Role
The Technical Documentation Specialist is responsible for:
  • Preparing and maintaining compliant medical device technical documentation, with clear evidence mapping and traceability across the product lifecycle.

  • Supports new and commercial products, including technical files for new and legacy devices.

  • Contributing towards SDI Strategic Priorities.

  • Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.

    • Specific Responsibilites
  • Prepares, reviews and maintains technical file documentation for new and legacy medical devices, ensuring content is clear, complete, evidence-based and suitable for regulatory submission or audit review.

  • Ensures technical documentation demonstrates compliance with applicable requirements, including EU MDR Annex II/III, GSPRs, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP and relevant product standards.

  • Develops and maintains traceability matrices linking regulatory requirements, GSPRs, design inputs/outputs, risks and controls, verification/validation evidence, labelling, claims and post-market data.

  • Provides quality and regulatory input to submissions, technical documentation updates, design changes and product lifecycle activities.

  • Collaborates with R&D, Manufacturing, Quality, Regulatory and Marketing to embed compliance requirements in relevant processes and documentation.

  • Improves technical documentation templates, procedures and tools, including MDR evidence mapping and technical file traceability templates.

  • Supports Quality activities and ensures work is performed in accordance with the QMS, ISO 13485, MDSAP, EU MDR and other applicable requirements.

  • Supports risk management, design control and periodic standards review, including assessment of regulatory or standards changes that may impact products or technical documentation.

    • Key Relationships (Internal & External)
  • External – Equipment suppliers, laboratories, research organisations, consultants and regulators.

  • Internal – R&D, QA, QC, Regulatory Affairs, Manufacturing and Marketing.

    • Job Environment
    The position is located at Bayswater and Montrose
    Working hours: 38 hours per week

    Education Level
    Bachelor's Degree

    Essential Experience
  • Degree in a scientific, engineering or related discipline.

  • Experience in design control, risk management, verification/validation, document control and/or medical device technical documentation.

  • Experience preparing or maintaining EU MDR technical documentation, including Annex II/III and GSPR evidence alignment.

  • Practical understanding of EU MDR, ISO 13485, ISO 14971, MDSAP, FDA 21 CFR Part 820 and relevant IEC/ISO product standards.

  • Experience with traceability matrices is highly regarded.

  • 5+ years’ experience in Regulatory Affairs, Quality Assurance or Research and Development is desirable.

  • Proficient in MS Word, Excel, MS Project and other relevant computer software.

  • Able to summarise complex technical and regulatory information clearly.

    • Knowledge and skills
  • Aware of SDI’s current Quality policy and objectives.

  • Strong understanding of medical device technical documentation, manufacturing processes and quality management systems.

  • Ability to structure technical files and traceability matrices that demonstrate compliance through objective evidence.

  • Strong organisational skills, with the ability to prioritise tasks and support effective teamwork.

  • Excellent technical writing and communication skills.

    • Personal Qualities
  • Analytical, detail-oriented and quality-focused.

  • Team-oriented and able to work effectively with cross-functional stakeholders.

  • Able to work under pressure, reprioritise and meet deadlines.

  • Self-motivated, accountable, flexible and reliable.

    • Classification Level
    Special

    Currency
    AUD

    Salary Minimum
    $80,000.00

    Salary Maximum
    $120,000.00

    Salary Period
    Per Annum

    Benefits
    Superannuation
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